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Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction

Primary Purpose

Mediastinal Lymphadenopathy, Lung Malignancies

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endobronchial Ultrasound
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mediastinal Lymphadenopathy focused on measuring Endobronchial Ultrasound, transbronchial needle aspiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adult subjects who are scheduled to undergo endobronchial ultrasound transbronchial aspiration to sample mediastinal masses or lymph nodes.

Exclusion Criteria:

  • Patients who are not able to complete the EBUS procedure for any reason

Sites / Locations

  • Staten Island University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endobronchial Ultrasound

Arm Description

EBUS-TBNA is a procedure that allows accurate sampling of mediastinal lymph nodes and peribronchial lesions

Outcomes

Primary Outcome Measures

Diagnostic yield
The number of patients with cytological diagnosis as a measure of effective diagnostic technique.

Secondary Outcome Measures

Samples adequacy
adequate cytological material as a measure of effective diagnostic technique.

Full Information

First Posted
July 4, 2012
Last Updated
November 25, 2012
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT01734980
Brief Title
Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction
Official Title
Comparison Of Cytologic Accuracy Of Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples when no suction is applied.
Detailed Description
Endobronchial ultrasound-guided transbronchial needle aspiration which is known as the EBUS procedure is a low risk procedure performed using bronchoscopy to sample chest lesions. A needle is passed through the bronchoscope to biopsy the chest lesion. Every lesion is usually biopsied 3 to 7 times. In most cases the investigators apply a syringe with negative pressure to the needle inserted into lesion for biopsy. In some cases the investigators don't apply any negative pressure. There are no studies to evaluate which one is better, applying syringe suction or no suction. In our study, the investigators are planning to do biopsies with or without suction. Then, the pathology samples will be evaluated for any cytologic difference in making the diagnosis. Any patient undergoing the EBUS procedure for chest biopsies will be eligible. Every lesion will be biopsied at least twice with needle with and without suction. The biopsy samples will be then divided into group A where the investigators applied syringe suction and group B where no syringe suction was applied. There is no risk to the patient in addition to the risk of the EBUS procedure itself. The investigators are not performing any additional intervention from the usual standard of care for any patient presenting for the EBUS procedure. Essentially the investigators are simply grouping the suction and no suction pathology samples as A and B for pathologic comparison. RESULTS: Among the 26 participants, one of the patients (3.8%) had no adequate tissue using both methods; one patient (3.8%) had adequate tissue using suction but no adequate tissue using no suction; and 24 patients had adequate tissue using both methods (92.3%, p= 1.00). Among the twenty-four patients with adequate tissue using both methods, 14 patients (58.3%) had benign pathology using both methods, while ten patients (41.7%) had malignant pathology using both methods (p= 1.00). Considering suction to be the golden method, the sensitivity and specificity of no suction were 100%. Among the 32 sites that were sampled, one site (3.1%) had no adequate tissue using both methods; one site (3.1%) had adequate tissue using suction but no adequate tissue using no suction; and 30 sites had adequate tissue using both methods (93.8%, p= 1.00). Among the thirty sites with adequate tissue using both methods, 17 (56.7%) had benign pathology using both methods; 12 (40.0%) had malignant pathology using both methods; and one site (3.3%) had malignant pathology using suction, but benign pathology using no suction (p= 1.00). Considering suction to be the golden method, the no suction had a sensitivity= 92.3% and specificity= 100%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Lymphadenopathy, Lung Malignancies
Keywords
Endobronchial Ultrasound, transbronchial needle aspiration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endobronchial Ultrasound
Arm Type
Experimental
Arm Description
EBUS-TBNA is a procedure that allows accurate sampling of mediastinal lymph nodes and peribronchial lesions
Intervention Type
Procedure
Intervention Name(s)
Endobronchial Ultrasound
Intervention Description
The samples will be divided as 2 groups for comparison. Group A is the group of samples where we apply negative pressure syringe for needle suction. Group B is where no suction will be applied after needle insertion.
Primary Outcome Measure Information:
Title
Diagnostic yield
Description
The number of patients with cytological diagnosis as a measure of effective diagnostic technique.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Samples adequacy
Description
adequate cytological material as a measure of effective diagnostic technique.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult subjects who are scheduled to undergo endobronchial ultrasound transbronchial aspiration to sample mediastinal masses or lymph nodes. Exclusion Criteria: Patients who are not able to complete the EBUS procedure for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Chalhoub, MD
Organizational Affiliation
Staten Island University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States

12. IPD Sharing Statement

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Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction

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